Product and Service Suppliers for Hyperbaric Medicine

Hyperbaric Chamber Manufacturers

Manufacturers of hyperbaric chambers with
FDA clearance for UHMS-approved diseases and conditions

Hospitals, outpatient facilities, and independent hyperbaric clinics treating diseases and conditions for which hyperbaric oxygen therapy has been approved by the Hyperbaric Oxygen Committee of the Undersea and Hyperbaric Medical Society (UHMS) use hard-walled monoplace and multiplace chambers. These chambers are regulated as Class II medical devices by the US Food and Drug Administration and approved for use with 100% oxygen at 2 ATA (atmospheres of pressure absolute, about 29.39 psi) or higher.

ETC Biomedical Systems »

ETC Biomedical Systems has been manufacturing hyperbaric chambers for over 40 years, achieving a number of firsts in chamber design during that time. ETC chambers are used in hospitals and outpatient facilities throughout the world.

Fink Engineering, Pty. Ltd. »

Fink Engineering combines an innovative design approach with state-of-the-art engineering and fabrication facilities to redefine the form and function of multiplace medical hyperbaric chambers.

Gulf Coast Hyperbarics, Inc.

Lynn Haven, Florida

HyperTec, Inc.

Olney, Texas

Khrunichev Medical

Khrunichev Space Center, Russia

OxyHeal Health Group

National City, California

Pan-America Hyperbarics, Inc.

Richardson, Texas

Perry Baromedical Corporation

Riviera Beach, Florida

Reimers Systems, Inc.

Lorton, Virginia

Sands Hyperbaric Corporation

San Diego, California

Sechrist Industries, Inc.

Anaheim, California

Other manufacturers of hyperbaric chambers

The following manufacturers have not received FDA clearance to market their products in the US. Their chambers conform to European technical specifications and health and safety standards.

Haux-Life-Support GmbH

Karlsbad, Germany

Hyperbaric Technology (HyTech) B.V.

Raamdonksveer, The Netherlands

Manufacturers of hyperbaric stretchers

These new devices are transportable chambers that deliver 100% oxygen at hyperbaric pressures and include integrated oxygen and power supplies and monitoring and control systems. These manufacturers have received FDA clearance to market their products to treat the diseases and conditions approved by the Hyperbaric Oxygen Committee of the Undersea and Hyperbaric Medical Society.

SOS Hyperlite. Ltd

Douglas, Isle of Man, UK

Manufacturers of portable "mild hyperbaric" chambers

Mild HBOT is administered in inflatable bags that operate with room air (21% oxygen) at slightly increased pressure (< 1.5 ATA). These manufacturers of mild hyperbaric bags have received FDA clearance to market their devices for the treatment of Acute Mountain Sickness(AMS) only.

  • Treatment of AMS with a portable hyperbaric device simulates conditions at lower altitudes (where the atmospheric pressure is higher) when bad weather or other factors make climbing down dangerous or impossible.
  • Mild hyperbaric devices are not FDA-cleared for the treatment of any UHMS-approved diseases and conditions.
  • The UHMS warns that hyperbaric treatment should not be self-administered or administered by nonprofessionals in the home.
  • The National Board of Diving and Hyperbaric Medical Technology (NBDHMT), the certifying authority for hyperbaric technologists and nurses, has stated that "the design, fabrication and common use of portable, fabric, low-pressure (operating at pressures of no greater than 1.4 ATA) hyperbaric chambers is inconsistent with recognized and prevailing safety codes and standards." Read the full NBDHMT statement »

Some of these companies or their dealers may also sell oxygen concentrators. Oxygen concentrators are not intended for use with hyperbaric devices and such misuse may create a safety hazard.

  • Use of oxygen concentrators with mild hyperbaric devices has not been cleared by the FDA.
  • Use of an oxygen concentrator with mild hyperbaric devices is illegal in most US states.
  • Your insurance may not cover property damage, injury, or death resulting from unlawful use of an oxygen concentrator in combination with these devices.

caution sign

Important Note: The following companies, or other companies that resell or use the products made by these companies, may make claims that are not in compliance with FDA labeling regulations. HyperbaricLink has no association with these companies and expressly disclaims any connection to the statements made by these companies.

HyperbaricsRx

Sunrise, Florida

Pressure Tech, Inc.

Freeport, New York

Summit to Sea, LLC

Mound, Minnesota
(Registered Agent for Certec, Sourcieux Les Mines, France)

Key Pages

FDA Clearance and UHMS Approval »

Hyperbaric Chamber Types »

Key Websites

US Food and Drug Administration

Undersea and Hyperbaric Medical Society

American Society of Mechanical Engineers

National Fire Protection Association

Important information about
hyperbaric chamber safety regulations

The US Food and Drug Administration (FDA) regulates the marketing of hyperbaric chambers as Class II medical devices. Federal and state regulators work to ensure that hyperbaric chambers are safe for human occupancy and operation, in conformity with standards set by the American Society of Mechanical Engineers (ASME) and the National Fire Protection Association (NFPA).

Like other medical devices, hyperbaric chambers are designed to be operated by trained medical professionals. The National Board of Diving and Hyperbaric Medical Technology (NBDHMT) credentials Certified Hyperbaric Technologists (CHT) in the US.

  • Use of a hyperbaric chamber for unapproved or “off-label” diseases and conditions may not be safe and effective.
  • Operating a hyperbaric chamber in ways other than those approved by the manufacturer, or in violation of federal or state law, or by unqualified personnel, may result in serious injury or death.

Other products and services for hyperbaric oxygen therapy

Manufacturers and Distributors of HBOT Accessories and Systems »

Treatment Center Management, Operations, and Consulting Services »

Sources
US Food and Drug Administration, Center for Devices and Radiological Health. Retrieved 11 August 2011.
http://www.fda.gov/MedicalDevices/default.htm
Page Data
Updated: 14 Aug 2011 11:16 PM
Created: 29 Sep 2010 02:29 PM
By: About the authors »